DEVICE: Poly-Tape 30mm x 800mm (05060267131812)
Device Identifier (DI) Information
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
46242 | Surgical support tape, non-bioabsorbable |
A band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.
|
Active | true |
13906 | Polyester suture, non-bioabsorbable, multifilament |
A multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.
|
Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
FTL | Mesh, Surgical, Polymeric |
OWX | Mesh, Surgical, Non-Absorbable, Orthopaedics, Reinforcement Of Tendon |
QUW | Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament |
JDR | Staple, Fixation, Bone |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K010051 | 000 |
K222978 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
e466786a-63ff-487a-939a-a230eabb0ab2
November 22, 2024
3
July 03, 2023
November 22, 2024
3
July 03, 2023
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+4401132387202
enquiries@xiros.co.uk
enquiries@xiros.co.uk